Tonix Pharmaceuticals Reports First Quarter 2019 Financial Results and Operational Highlights Phase 3 RECOVERY Trial of Tonmya for the Treatment of PTSD is Enrolling; Topline Data Expected First Half of 2020

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Pharmaceuticals Reports First Quarter 2019 Financial Results and Operational Highlights

Phase 3 RECOVERY Trial of Tonmya

for the Treatment of PTSD is Enrolling; Topline Data Expected First Half of 2020

NEW YORK, May 13, 2019 (GLOBE NEWSWIRE) -- Tonix

Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company developing pharmaceutical

products to treat psychiatric and pain conditions, and biological products to improve biodefense, today announced financial results

for the quarter ended March 31, 2019, and an overview of recent operational highlights. Tonix's lead program is TNX-102 SL,

or Tonmya* (cyclobenzaprine HCl sublingual tablets), for the treatment of posttraumatic stress disorder (PTSD), which was granted

Breakthrough Therapy designation, and which is currently being studied in a Phase 3 efficacy trial.

"We initiated the Phase 3 RECOVERY study of

Tonmya for the treatment of PTSD in March, and we are pleased with the progress of enrollment thus far. We anticipate topline results

in the first half of next year as previously guided," said Seth Lederman, M.D., President and Chief Executive Officer. "RECOVERY

is different from our previous trials in PTSD in two important ways. First, RECOVERY is restricted to patients with PTSD resulting

from trauma within 9 years of screening. Our prior studies in military-related PTSD have shown that PTSD is a potentially treatable

condition, particularly if treatment is initiated within 9 years of trauma. Second, RECOVERY is recruiting civilians with PTSD

in addition to those with military-related PTSD. Affecting approximately 12 million adults in the U.S., PTSD remains an area of

high unmet medical need in both the civilian and military populations."

has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for

the treatment of PTSD. TNX-102 SL is an investigational new drug and has not been approved for any indication.

First Quarter 2019 Financial

Research and development expenses

for the first quarter of 2019 totaled $3.9 million, compared to $5.2 million for the same period in 2018. This decrease is primarily

due to a pharmacokinetic bridging study of TNX-102 SL that was conducted in the first quarter of 2018.

General and administrative expenses

for the first quarter of 2019 totaled $2.4 million, compared to $1.8 million for the same period in 2018. This increase is primarily

due to investor and public relations activities and an increase in insurance expenses due to higher premiums in 2019.

Net loss was $6.2 million, or

$1.29 per share, for the first quarter of 2019, compared to net loss of $6.9 million, or $8.80 per share, for the first quarter

of 2018. The weighted average common shares outstanding for the first quarter of 2019 was 4,848,199 shares. The weighted average

common shares outstanding for the first quarter of 2018 was 787,900 shares.

At March 31, 2019, Tonix had $16.4

million of cash and cash equivalents, compared to $25.0 million as of December 31, 2018. Cash used in operations was $8.6 million

for the three months ended March 31, 2019, compared to $6.8 million for the three months ended March 31, 2018. The increase in

cash used in operations during the first quarter of 2019 is due primarily to non-recurring items, including close-out costs for

the Phase 3 HONOR study and start-up costs related to the current Phase 3 RECOVERY study. Costs related to the RECOVERY study are

expected to decrease on a quarterly basis going forward. Additionally, the Company's annual insurance premiums increased

over the prior year, the payments of which occur in the first quarter.

About Tonix Pharmaceuticals

Tonix is a clinical-stage

biopharmaceutical company focused on discovering and developing pharmaceutical products to treat psychiatric and pain conditions,

and biological products to improve biodefense through potential medical counter-measures. Tonix's lead program is the development

of Tonmya (TNX-102 SL), which is in Phase 3 development as a bedtime treatment for PTSD. Tonmya for PTSD has been designated a

Breakthrough Therapy by the FDA. Tonix is also developing TNX-102 SL as a bedtime treatment for fibromyalgia and agitation in Alzheimer's

disease under separate Investigational New Drug applications (IND) to support potential pivotal efficacy studies. The fibromyalgia

program is in Phase 3 development and the agitation in Alzheimer's program is Phase 2 ready. In fibromyalgia, TNX-102 SL

acts as a non-opioid, centrally-acting analgesic that would provide a new therapeutic option for fibromyalgia patients. The agitation

in Alzheimer's disease IND has been designated a Fast Track development program by the FDA. TNX-601 (tianeptine oxalate)

is in the pre-IND application stage, also for the treatment of PTSD but by a different mechanism from TNX-102 SL and designed for

daytime dosing. TNX-601 is also in development for a potential indication - neurocognitive dysfunction associated with corticosteroid

use. A Phase 1 clinical formulation selection pharmacokinetic study of TNX-601 will be conducted outside of the U.S. in 2019. Tonix's

lead biologic candidate, TNX-801, is a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus,

currently in the pre-IND application stage.

This press release and further information about Tonix

can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking

within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking

words such as "anticipate," "believe," "forecast," "estimate," "expect,"

and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results

could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated

by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances

or approvals and noncompliance with FDA regulations; our need for additional financing; uncertainties of patent protection and

litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence

upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the

development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise

any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year

ended December 31, 2018, as filed with the Securities and Exchange Commission (the "SEC") on March 18, 2019, and periodic

reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all

such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

TONIX PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In Thousands, Except Share and Per Share Amounts)

TONIX PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED BALANCE SHEETS

(1) The condensed consolidated

balance sheet for the year ended December 31, 2018 has been derived from the audited financial statements but does not include

all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial

Tonix Pharmaceuticals

Scott Stachowiak (media)

Peter Vozzo (investors)